Have you ever "excluded" certain job descriptions from the QMS?

[QE1993]

In order to fill gaps in our Training, I assigned relevant procedures for each Job Description at our company. I created this matrix based on on the documented job description and the extent to which I felt that position was involved with the documents/procedures.

My Controlled threw a fit and said she and her people have nothing to do with the QMS and shouldn't be included.

I haven't met with her regarding this yet, but I have a strong suspicion that she is afraid auditors will "interview" her people during the audit and this could lead to them looking at financial documents (which I can imagine no scenario in which a QMS auditor would look at sensitive financial information).

I know her ultimate question will be if she and her team can be excluded entirely from the QMS? Is this allowed/possible, have you done it?

She's part of senior management, so she's a big pat of management commitment, but we can say she's not part of it for the sake of the QMS? Any thoughts?

 

[Sidney Vianna]

My Controlled threw a fit and said she and her people have nothing to do with the QMS and shouldn't be included.

What is the context of your organization and what processes are "her people" involved with?

In some business contexts, mainly dealing with consumers, one of the biggest sources for customer dissatisfaction is erroneous billing. Even in B[sub]2[/sub]B scenarios, mistaken invoicing can lead to tremendous friction between customers and suppliers. Business relationships cease every day over that.

A long time ago I started the Should the billing process be part of ISO 9001:2008? thread.

Irrespective of what ISO 9001 says or requires, in my mind, some financial processes have a close connection with customer satisfaction. Ignore that at your own peril.

 

[QE1993]

Her employees include the office coordinator, the accountant, and HR.

(An odd mix to have the Controller as their manager, but it is what it is).

HR plays a significant role in hiring and recruiting resources and conducting on-board Training. There is no way HR can be excluded from our QMS.

The Accountant issues credit memos to customers if there is a returned product that we need to provide them credit for. So I have her trained to a RMA processing wki.

The office coordinator creates the Job Travelers for all jobs. this includes printing out IPs, printing out product identification labels, etc. This is a big part of our planning process. She is also involved in scanning in DHR's (not reviewing them, just scanning them in). So i have her trained to Product identification, tractability, and realization. She is solely responsible for creating the identification stickers for every job - she needs to know what information goes on them (JN, PN, etc.).

I also, as a general rule, have everyone trained to the Control of Docs and Control of Records procedures, since I believe there should be a general awareness of the type of documentation we have a the company, that we control these procedures, and how to treat records.

I just don't know how to make her realize that just because she and her employees carry out certain functions that are part of the QMS, doesn't mean her entire financial realm becomes parts of the QMS.

 

[Sidney Vianna]

I just don't know how to make her realize that just because she and her employees carry out certain functions that are part of the QMS, doesn't mean her entire financial realm becomes parts of the QMS.

The S in QMS stands for System. A system is comprised of processes; not people, not departments, not documents, but processes. As long as a process can impact product conformity and/or customer satisfaction, that process IS part of the QMS, irrespective of what department, grade level, color, gender, creed, etc...that person belongs to.

 

[Golfman25]

Her employees include the office coordinator, the accountant, and HR.

(An odd mix to have the Controller as their manager, but it is what it is).

HR plays a significant role in hiring and recruiting resources and conducting on-board Training. There is no way HR can be excluded from our QMS.

The Accountant issues credit memos to customers if there is a returned product that we need to provide them credit for. So I have her trained to a RMA processing wki.

The office coordinator creates the Job Travelers for all jobs. this includes printing out IPs, printing out product identification labels, etc. This is a big part of our planning process. She is also involved in scanning in DHR's (not reviewing them, just scanning them in). So i have her trained to Product identification, tractability, and realization. She is solely responsible for creating the identification stickers for every job - she needs to know what information goes on them (JN, PN, etc.).

I also, as a general rule, have everyone trained to the Control of Docs and Control of Records procedures, since I believe there should be a general awareness of the type of documentation we have a the company, that we control these procedures, and how to treat records.

I just don't know how to make her realize that just because she and her employees carry out certain functions that are part of the QMS, doesn't mean her entire financial realm becomes parts of the QMS.

Based on this, she, some of her processes, is/are definitely part of the the QMS. I'd tell her to pound sand and shut up -- nobody in the company should be "exempt." At best, not applicable.

More diplomatically, you could just print out your above response and say look at how involved your people are in the QMS. And no, the auditor is not a financial auditor. The closest they'll get to looking at financial documents will maybe be a purchase order for materials.

 

[hogheavenfarm]

Sounds very much like a part of management doesn't want the responsibility for the Quality system. Very common is the belief that the QMS is the quality persons job, not theirs. The standard says otherwise.

 

[ScottK]

Short answer... no.
I have excluded processes that are not in the scope of the QMS, such as certain financial processes and reporting, but the QMS is for the whole company, not part of it.
I think your controller needs some training on what a QMS is.
You're in the 13485 forum so I would also point out that government regs must also be considered. While an FDA inspector, for example, would not likely look at an accountant's training record they may very well ask for HR and office manager.

And as it's a company system if you have a training matrix for some you should have it for all.

 

[Mike S.]

QE1993 I think you have received some good replies above.

You are not alone -- I am in the AS9100 world but once upon a time also had the VP of Finance/Controller (who also controlled IT, invoicing, and quoting) insisting none of his people should be involved in the QMS. Sigh.

Of course he had to be shown the light, but by a more senior person than a lowly QE who was not fit to be in the same room as His Lordship, let alone address Him directly.

 

[AndyN]

In order to fill gaps in our Training, I assigned relevant procedures for each Job Description at our company. I created this matrix based on on the documented job description and the extent to which I felt that position was involved with the documents/procedures.

My Controlled threw a fit and said she and her people have nothing to do with the QMS and shouldn't be included.

I haven't met with her regarding this yet, but I have a strong suspicion that she is afraid auditors will "interview" her people during the audit and this could lead to them looking at financial documents (which I can imagine no scenario in which a QMS auditor would look at sensitive financial information).

I know her ultimate question will be if she and her team can be excluded entirely from the QMS? Is this allowed/possible, have you done it?

She's part of senior management, so she's a big pat of management commitment, but we can say she's not part of it for the sake of the QMS? Any thoughts?

The answer lies with the Top Dog on whether "Big Pat" (or whatever her name is) is the owner of any QMS processes and should therefore be included. Since they provide insight to customers and their satisfaction as well as budget, quality costs and so on, - as others have rightly suggested - it's tough to ignore them. I'd suggest the response is based on fearing the unknown...

 

[QE1993]

Thanks everyone for your responses. It helped me stand stronger in my resolve that "excluding" her and her employees goes against the very intent of the standard - to have a unifying system that promotes continuously improving our processes and consistently meeting all our requirements. To exclude any one person, especially a manager, would look so bad.

I thought a lot about what I wanted to say to her at the meeting we had scheduled to discuss this.

I was actually further annoyed by her because within a couple of hours of me sending the training requirements to everyone, she sneakily (in my opinion) changed the Office Manager job description to include the phrase "purely administrative" throughout. Nice try.

I was all set to go in to her and say "Fine. We can "Exclude" you from anything to do with quality, but when an auditor comes here and asks for training records of HR (who does training herself) or the office manager (who is creating all of our work routers) and I have nothing to show them because 'their manager wanted them excluded from the QMS,' I"ll expect you to deal with the ensuing "lack of management commitment" and/or "insufficient training provided" NC's that will likely follow."

I decided to take a far more diplomatic approach lol. Essentially, she was concerned about auditors coming up to her and asking her for documented procedures of everything that she and her accountant do. She was also concerned that singing her name on a training record would commit her to that actual task (for example, I have trained to the Management Review procedure, but per my quality director's, its optional for her to attend), and she was afraid signing the training record would require her to attend every management review.

We were able to agree on the root cause for her concerns - she was managing positions that were outside the scope of her expertise. I told her that was above my pay grade to make a decision on and she probably should have a conversation with our GM regarding that.

Her concerns were valid for someone who had not been properly explained what a QMS is and what a QMS audit is.

It was a great learning experience for me, actually. Most people don't care enough to question me on things I ask them to do...it shows an awareness on her part and it forced me to explain myself more than I've ever had to.